Heater-Cooler Unit HCU 40 (2018-08-03)
- Starting date:
- August 3, 2018
- Posting date:
- August 17, 2018
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-67454
Affected products
Heater-Cooler Unit HCU 40
Reason
The vacuum valve is located in both, the patient and the cardioplegia water circuit. Maquet cardiopulmonary has received complaints in relation to device malfunctions caused by leaking vacuum valves. This issue is serial number specific and only 3 affected serial numbers were sold in Canada. The bacteriostatic agent used in the storage and distribution phase of manufacturing compromised the tightness of the vacuum valve. This has been identified and changed.
Affected products
Heater-Cooler Unit HCU 40
Lot or serial number
- S/N 90440575
- S/N 90440576
- S/N 90440577
Model or catalog number
70104.4054 (200-240V)
Companies
- Manufacturer
-
Maquet Cardiopulmonary GmbH
Kehler Str. 31
Rastatt
76437
GERMANY